Catheter protective shield

ABSTRACT

This subject invention is a protective shield for protecting indwelling medical devices, during showering, bathing, or swimming. This protective shield comprises an inner bag having an opening containing by a medical grade absorbent material, where the opening is surrounded by a medical grade adhesive for attachment to a patient&#39;s skin. The medical device in inserted into the bag through the absorbent material. This bag is covered by an attached outer cover, which has an adhesive material applied along it peripheral edge or attachment to the patient, which diverts the flow of fluid away from the opening of the inner bag. The absorbent material in opening of the inner bag traps and hold fluid penetrating the two adhesive barriers affording additional level of protection in preventing fluid from reaching the inside of the pouch.

FIELD OF THE INVENTION

[0001] The present invention relates to a protective device for acatheter and or device that transcends from the outside of the body tothe inside of the body, and more particularly to a protective devicewhich decreases the amount of foreign material (fluid and/or debris)presented to the catheter and its corresponding exit site, decreasingthe risk of foreign material reaching the inside of the body.

BACKGROUND OF THE INVENTION

[0002] With the improvement in healthcare over the last several decades,there is an increasing number of patients living with indwellingcatheters traveling from the inside to the outside of their bodies.These catheters are being used for a variety of reasons such asdialysis, chemotherapy, alimentation, and fluid drainage, to name a few.The protection of the catheter and corresponding exit site is asignificant concern for these patients, as moisture or other materialcan support the growth of harmful or infectious bacteria in and aroundthe exit site.

[0003] As such, these patients ability to perform normal dailyactivities, such as swimming, bathing, and even showering is severallylimited, and can even become prohibited for many of the patients. As aresult, even when the patient begins to recover, the catheter becomes aconstant reminder of their illness.

[0004] Accordingly, there remains a need for a device for protecting acatheter and corresponding exist site during such activities asswimming, bathing, or showering.

BRIEF SUMMARY OF THE INVENTION

[0005] The protective shield of the subject invention provides a meansfor protecting an indwelling catheter and corresponding exit site fromdirt, debris, and moisture. The protective shield comprises a pair ofprotective layers, an inner bag and an outer cover. The inner bag isdesigned for receiving the proximal end of the catheter, having a frontside and a backside, with the front side having an opening therethrough.Positioned and affixed within the front side opening is a moistureabsorbent material, where the moisture absorbent material comprises asubstantially centrally positioned slit therethrough. The inner bagfurther comprises a moisture resistant adhesive material suitable forapplication to the patient's skin, where the adhesive material isapplied to the outer surface of the front side of the inner bag,substantially surrounding the opening without discontinuity, such that aprotective seal can be formed when the inner bag is applied to thepatient's skin.

[0006] The outer cover comprises a sheet of flexible, fluid-impermeablematerial having a peripheral edge that adheres to the patients skin,surrounding the inner bag. A moisture resistant adhesive materialsuitable for application to the patient's skin is applied to theperipheral edge without discontinuity, such that a protective seal canbe formed when the outer cover is applied to the patient's skin. Theouter cover is sized such that the inner bag is encompassed within theperipheral edge. The outer cover serves as a tarp to move water awayfrom the inner bag.

[0007] In use, a catheter is inserted into the inner bag by insertingthe catheter though the slit in the absorbent material. The catheter isdrawn into the bag until the absorbent material abuts the catheter exitsite and surrounding area. The inner bag is secured in position by theadhesive material in contact with the patient's skin. The outer cover ispositioned over the inner bag, such that the inner bag is positionedwithin the peripheral edges of the outer cover. The outer cover issecured in position by the adhesive material in contact with thepatient's skin. The bag can be removed by peeling the outer cover fromthe patient's skin. The inner bag is gently peeled from the patient'sskin and the catheter removed from the bag. The protective shield isthen discarded.

[0008] An advantage of this invention is that the shield decreases therisk of foreign material reaching the inside of the body.

[0009] These and other objects, features and advantages of the presentinvention will be more readily understood with reference to thefollowing detailed description, read in conjunction with theaccompanying drawing figures.

[0010] All patents, patent applications and publications referred to orcited herein, or from which a claim for benefit of priority has beenmade, are incorporated by reference in their entirety to the extent theyare not inconsistent with the explicit teachings of this specification,including: U.S. Pat. No. 4,415,642 to Shepherd, U.S. Pat. No.4,5,495,856 to Fentress, and U.S. Pat. No. 6,222,090 to Weston.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011]FIG. 1 depicts a perspective view of the catheter protectiveshield.

[0012]FIG. 2 depicts a front view of the catheter protective shield.

[0013]FIG. 3 depicts a perspective view of the outer cover.

[0014]FIG. 4 depicts a perspective view of the inner bag.

[0015]FIG. 5 depicts a perspective view of the absorbent material.

[0016]FIG. 6 depicts a perspective view of the inner bag with theabsorbent material.

[0017]FIG. 7 depicts a perspective view of the inner bag with an annularring.

[0018]FIG. 8 depicts a perspective view of the outer cover with anannular ring.

[0019]FIG. 9 depicts a perspective view of a catheter within theprotective shield.

DETAILED DISCLOSURE OF THE INVENTION

[0020] The protective shield 10 of the subject invention provides ameans for protecting an indwelling catheter and corresponding exit sitefrom dirt, debris, and moisture.

[0021] In an embodiment, as shown in FIGS. 1-2, the protective shield 10of the subject invention comprises a first protective layer 12 and asecond protective layer 14. The first 12 and second protective layers 14are made from a flexible, fluid-impermeable material capable ofconforming to a patient's skin, including, but not limited to plastic,polymer, latex, or rubber. Additionally, it is desirable that thematerial be substantially impervious to bacterium, fungi, viruses, andother infectious agents.

[0022] As shown in FIGS. 4-6 and 9, the first protective layer 12comprises an inner bag 16 for receiving the proximal end 51 of thecatheter 50, having a front side 18 and a backside 20, where the frontside 18 has an opening 22 therethrough. Positioned and affixed withinthe front side opening 22 is a moisture absorbent material 24, where themoisture absorbent material 24 comprises a substantially centrallypositioned slit 26 therethrough. The moisture absorbent material 24 cancomprise conventional absorbent paper, fiber, or cloth materials.Additionally, the absorbent material 24 can include conventional agentsthat trap, stabilize or otherwise capture the moisture into a non-mobileform. The inner bag 16 further comprises a moisture resistant adhesivematerial 28 suitable for application to the patient's skin, where theadhesive material 28 is applied to the outer surface of the front side18 of the inner bag 16, substantially surrounding the opening 22,without discontinuity such that a protective seal can be formed when theinner bag 16 is applied to the patient's skin.

[0023] In an embodiment the inner bag 16 is rectangular, circular,elliptical, or other suitable shape.

[0024] In an embodiment the opening 22 is rectangular, circular,elliptical, or other suitable shape.

[0025] In an embodiment the adhesive material 28 is covered by aremovable release layer, such that the catheter 50 may be inserted intothe inner bag 16 without adhering to the adhesive material 28.

[0026] In an alternative embodiment, as shown in FIG. 7, the inner bag16 further comprises an annular ring 32, where the annular ring 32 isaffixed about the opening 22 of the inner bag 16. The annular ring 32 ismade of a flexible material capable of conforming to the surface of apatient's skin.

[0027] As shown in FIG. 3, the second protective layer 14 comprises anouter cover 34 having a peripheral edge 36 that when adhered to thepatients skin, surrounds the inner bag 16. A moisture resistant adhesivematerial 28 suitable for application to the patient's skin is applied tothe peripheral edge 36 without discontinuity such that a protective sealcan be formed when the outer cover 34 is applied to the patient's skin.The outer cover 34 is sized such that the inner bag 16 is encompassedwithin the peripheral edge 36.

[0028] In an embodiment the second protective layer 14 is rectangular,circular, elliptical, or other suitable shape.

[0029] In an alternative embodiment, as shown in FIG. 8, the outer cover34 further comprises an annular ring 38, where the annular ring 38 isaffixed about the peripheral edge 36 of the outer cover 34. The annularring 38 is made of a flexible material capable of conforming to thesurface of a patient's skin.

[0030] In an embodiment, as shown in FIGS. 1 and 2, the inner bag 16 isaffixed to the outer cover 34, where the top edge 21 of the protectedbag 16 is affixed to the outer cover 34.

[0031] In a method of use, as shown in FIGS. 2 and 9, a catheter 50 isinserted into the inner bag 16 by inserting the proximal end 51 of thecatheter 50 though the slit 26 in the absorbent material 24. Thecatheter 50 is drawn into the inner bag 16 until the absorbent material24 abuts the catheter 50 exit site and surrounding area. The inner bag16 is secured in position by the adhesive material 28 contacting withthe patient's skin forming a protective seal. The outer cover 34 ispositioned over the inner bag 16, such that the inner bag 16 ispositioned with the peripheral edges 36 of the outer cover 34. The outercover 34 is secured in position by the adhesive material 28 contactingthe patient's skin, such that the outer cover 34 forms a protective sealabout the inner bag 16, protecting the inner bag 16 from moisture, dirt,and debris.

[0032] Following are examples which illustrate procedures for practicingthe invention. These examples should not be construed as limiting. Allpercentages are by weight and all solvent mixture proportions are byvolume unless otherwise noted.

EXAMPLE 1 Catheter Protective Shield in the form of an Inner Pouch andOuter Tarp

[0033] The protective shield consists of an inner plastic pouch whoseopening is surrounded by a medical grade absorbent material, which issurrounded by a medical grade adhesive that attaches to the patient. Themedical grade absorbent material covering the opening of the pouch, willtrap and hold fluid penetrating the adhesive barriers affording anadditional level of protection in preventing fluid from reaching theinside of the pouch. The pouch is of adequate size to accept the end ofa medical device existing the body. The protective shield furthercomprises an attached outer plastic tarp which covers the pouch, wherethe edged of the tarp is surrounded with medical grade adhesive, thatadheres to the patient, diverting the flow of fluid away from theopening of the pouch. The protective shield is designed to be used bypatients with medical devices exiting their bodies while they shower,bath, swim or perform activities where the device exist site from thebody is at risk of coming into contact with excessive fluid and/ordebris.

[0034] The adhesive is covered by a protective peel, allowing thepatient to insert the medical device through the absorbent material,into the pouch, without the adhesive sticking to the patient, tarp,pouch, or medical device. The protective peel is removed once themedical device is inserted through the absorbent material and the pouchis adhered to the skin. Similarly, once the pouch is in position, theprotective peel is removed from the tarp and the tarp is adhered to theskin, over the pouch.

[0035] The protective shield provides three layers of protection for themedical device and exit site. The first layer of protection is the tarp,directing the flow of water and/or debris away from the pouch. Thesecond layer of protection is the adhesive on the pouch, which protectsand seals the area surrounding the exit site. The third layer ofprotection is the adsorbent material. If water should be present in theopening of the pouch, the absorbent material will absorb it.

[0036] It should be understood that the example and embodimentsdescribed herein are for illustrative purposes only and that variousmodifications or changes in light thereof will be suggested to personsskilled in the art and are to be included within the spirit and purviewof this application and the scope of the appended claims.

1. A protective shield for providing a moisture barrier around thepuncture site of an indwelling catheter comprising: a) an inner baghaving at least one opening for placement over the catheter, whereinsaid opening comprises absorbent material affixed within, said absorbentmaterial formed for receiving an exposed end of the catheter, said innerbag further comprising an adhesive substantially surrounding saidopening for attachment to the skin, such that a protective seal can beformed between said inner bag and the skin; and b) an outer covercomprising a flexible sheet having adhesive about a peripheral edge foradhering to the skin over said inner bag such that said inner bag issealed beneath said outer cover forming a protective seal.
 2. Theprotective shield according to claim 1, wherein said inner bag and saidouter cover are made from a flexible, fluid impermeable material.
 3. Theprotective shield according to claim 2, wherein said flexible, fluidimpermeable material is plastic, polymer, silicon, vinyl, latex, orrubber.
 4. The protective shield according to claim 1, wherein saidinner bag and said outer cover are made from a material substantiallyimpervious to infectious agents.
 5. The protective shield according toclaim 1, wherein said inner bag comprises an annular ring integrallyformed with said opening.
 6. The protective shield according to claim 1,wherein said outer cover comprises an annular ring integrally formedwith said peripheral edge.
 7. The protective shield according to claim1, wherein said adhesive is a medical grade adhesive for application tothe skin.
 8. The protective shield according to claim 1, where in saidadhesive is a moisture resistant adhesive.
 9. The protective shieldaccording to claim 1, wherein said adhesive comprises a removable stripfor protecting said adhesive prior to use.
 10. The protective shieldaccording to claim 1, wherein said absorbent material comprises a slitformed for receiving the exposed end of the catheter.
 11. The protectiveshield according to claim 1, wherein said absorbent material is anabsorbent paper, absorbent fiber, or absorbent cloth.
 12. The protectiveshield according to claim 1, wherein said inner bag is affixed to saidouter cover.
 13. A protective shield for protecting an indwellingcatheter and exit site from moisture and debris comprising: a) aflexible, fluid-impermeable inner bag comprising a means for receiving aproximal end of a catheter projecting through the skin, said inner bagfurther comprising an adhesive substantially surrounding said means forreceiving the proximal end for attachment to the skin, such that aprotective seal can be formed between said inner bag and the skin; andb) an outer cover comprising means for adhering said outer cover to theskin, wherein said inner bag is sealed beneath said outer cover, suchthat a protective seal can be formed between said outer cover and theskin.
 14. The protective shield according to claim 14, wherein saidmeans for receiving a proximal end of a catheter projecting through theskin comprises an absorbent material.
 15. A protective shieldcomprising: a) an inner bag comprising an opening and an absorbentmaterial, wherein said absorbent material is affixed within said openingand said absorbent material is formed for receiving a proximal end of acatheter projecting through the skin, said opening comprises a means foradhering said opening to the skin, such that a protective seal can beformed between said inner bag and the skin; and b) an outer covercomprising a flexible sheet having a peripheral edge, wherein saidperipheral edge comprises means for adhering said peripheral edge to theskin, such that a protective seal can be formed between said peripheraledge and the skin, wherein when said outer cover is adhered to the skininner bag is sealed beneath said outer cover, within said peripheraledge.